# K952860: The Niner Nitinol Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Microvena Corp.
- Decided: Dec 13, 1995 after 174 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983033: Acs HT Balance Middleweight Guide Wire (1998), 17 descendants of its own
- K030617: PT2 Guide Wire and Addwire Extension Wire (2003), 11 descendants of its own
- K143587: ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire (2015), 6 descendants of its own
- K032183: IQ Hydrophilic Guide Wire (2003), 4 descendants of its own
- K040140: IQ Guide Wire (2004), 3 descendants of its own

Source page: https://510kreport.com/device/K952860
Methodology: https://510kreport.com/methodology